BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 8684489 · Received June 10, 2019

    Report

    Report Number
    0001038806-2019-00482
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 14, 2019
    Report Date
    October 1, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). SINCE PRODUCTS HAVE NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. NO FURTHER INVESTIGATION ON THE ABUTMENTS AS THEY REMAIN IN PLACE AND THERE NO ALLEGATION OF MALFUNCTION. FUNCTIONAL TESTING CAN NOT BE PERFORMED ON "LOOSENING" BECAUSE THE EVENT CAN NOT BE RECREATED ON A SINGLE USE ITEM. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE COMPLAINT THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. DOCUMENTS REVIEWED: BIOMET 3I RESTORATIVE PRODUCTS IFU (P-IIS086GR) REV E - NOVEMBER 2015 INFORMATION IDENTIFIED: 'WARNINGS' 'PRECAUTIONS' 'POTENTIAL ADVERSE EVENTS'. ¿SURGICAL MANUAL: TAPERED & PARALLEL WALLED IMPLANTS¿ INSTSM REV H 08/18 INFORMATION IDENTIFIED: TORQUE MATRIX - INTERNAL CONNECTION; PAGE III. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1190109). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1190109) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE REPORTED EVENT IS NON-VERIFIABLE WITH THE INFORMATION PROVIDED. IN ADDITION, SCREWS ARE DESIGNED AND MANUFACTURED FOR A SINGLE USE AND SHOULD NOT BE RE-TIGHTENED. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: DEVICE EVALUATED BY MANUFACTURER: CHANGE 'NO' TO 'YES'.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475339 CERTAIN® GOLD-TITE® HEXED SCREW SCREW NHA BIOMET 3I 1190109

    Patients

    Seq Age Sex Outcome Treatment
    1